Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET scans. The software is deployed via medical imaging workstations and is organised as a series of workflows which are specific to use with particular drug and disease combinations. The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET studies.

Device Description

Scenium display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data. The software is post processing and does not control the scanning features of the system.

AI/ML Overview

I am sorry, but the provided text does not contain a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for the Scenium device by Mirada Solutions Ltd., seeking clearance from the FDA. It mainly discusses:

General company and contact information.
Device description and its intended use (aid in assessment and quantification of pathologies from PET scans, particularly human brain scans using FDG-PET).
Technological characteristics and safety/effectiveness concerns, stating compliance with quality system regulations and ISO 14971.
A claim of substantial equivalence to predicate devices (NeuroQTM and GE Discovery ST).
The FDA's letter of substantial equivalence determination, allowing the device to be marketed.
The Indications for Use form.

While it mentions that "All requirements of the Emission Computed tomography system Standard, as outlined in 21 CFR 820.1200 have been met," and the software is in compliance with ISO 14971, it does not provide a table of acceptance criteria nor a detailed study that reports device performance against such criteria. The document focuses on regulatory clearance via substantial equivalence, not a performance study per se.

Therefore, I cannot provide the requested table and study details based on the information given.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Mirada Solutions. The word "mirada" is in bold, black letters on the top line. Below that, in smaller letters, is the word "solutions". To the right of the text is a stylized image of an eye.

Report Page 1 of 2 Type: Rev.Date: 20 November 2004 Doc.No: ms 5530 - 1 File Ref: RA Title: Scenium 510(k) summary information.

1 GENERAL INFORMATION

DEC 1 5 2004

Company and Contact Details:

Submitters Name:	Establishment Registration Number:
Mirada Solutions Ltd	3003493157
Address:	Tel.	Fax.
Level 1, 23-28 Hythe Bridge Street	44-1865-265 500	44-1865-265 501
City:	State:	Post code:	Country:
Oxford	OXON	OX1 2ET	United Kingdom
Contact Name in UK:	Contact Title:		Contact E-mail Address:
Michelle Sawyer	VP Quality&Regulatory Affairs		michelle.sawyer@mirada-solutions.com
Contact Name in US:	Contact Title in US:		Contact E-Mail Address in US:
Ms. Maria Ebio	Regulatory AffairsManager		maria.ebio@ctimi.com
Telephone Number in the US:865-218-2534	Fax Number in the US:865-218-3019	Contact Address in US:810 Innovation Drive, Knoxville, TN 37932

Proprietary name of Device: Scenium

Common Name of Device: Emission Computed tomography system, Product Code: 90KPS Classification: Class II: Sec. 21 CFR. 892.1200

Performance Standard: 21 CFR Subchapter H, Emission Computed tomography system Predicate Device(s):

510(k) No.	Trade name	Manufacturer	Component Applicable to
K041022	NeuroQTM	Syntermed, Inc	Display and analysis program
K041543	GE Discovery ST	GE Healthcare	Display and analysis program

Reason for submission: First market clearance application for the device.

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Image /page/1/Picture/0 description: The image shows the logo for Mirada Solutions. The word "mirada" is written in bold, black letters, with a small black circle above the "i". Below "mirada" is the word "solutions" in a smaller, lighter font. To the right of the text is a stylized graphic that appears to be an eye.

Device description:

Scenium display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data.

The software is post processing and does not control the scanning features of the system.

Summary of intended uses:

The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET scans. The software is deployed via medical imaging workstations and is organised as a series of workflows which are specific to use with particular drug and disease combinations.

The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET studies.

Technological characteristics:

This software is similar in uses and applications to those of the predicate devices. Both this and the predicate devices are used to assist the Clinician with the visual evaluation, assessment and quantification of pathologies derived from PET scans.

Safety and effectiveness concerns:

The device is designed and manufactured under Quality system regulations as outlined in 21 CFR & 820 .All requirements of the Emission Computed tomography system Standard, as outlined in 21 CFR 820.1200 have been met and additionally the software is in compliance with the requirements of ISO 14971 - Medical Devices application of risk management.

Substantial equivalence:

Based upon the above considerations, Mirada believes that the Scenium software is substantially equivalent to the chosen predicate devices. The Scenium software and the predicate devices are all post-processing and provide the same features of visualization and numeric data.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2004

Mirada Solutions Ltd. % Ms. Maria Ebio Regulatory Affairs Manager CTI Medical Imaging 810 Innovation Drive KNOXVILLE TN 37932

Re: K042863 Trade/Device Name: Scenium display and analysis software Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 KPS and LLZ Dated: October 18, 2004 Received: October 18, 2004

Dear Mr. Ebio:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CATION AND FOR FOR INDICATION FOR USE FORM IN

Ver/ 3 - 4/24/96

Applicant: Mirada Solutions Ltd.

510(k) Number (if known):	K 042863
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Device Name: Scenium

Indications for Use:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescriptive Use	✓
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Over – The – Counter Use
--------------------------	--

(Per 21 CFR 801.109)

(Per 21 CFR 801.109) (Optional Format 1-2-96) Truthful and Accurate Statement

David A. Ingram

(Division Sian-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.